A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease

HIV Infections Clinical Trial

Official title:

A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002110
• Other study ID #: 211A
• Secondary ID: CYST-9304
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: October 1995
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To determine the safety and tolerance of low-dose versus high-dose cysteamine administered concurrently with zidovudine (AZT). To determine the pharmacokinetics and effects on immune function and viral load in patients receiving these drug regimens.

Description:

Patients receive high or low doses of cysteamine plus AZT or placebo plus AZT. The target dose of cysteamine is determined by titration of the dose over a 6-week period, after which the patient receives 24 additional weeks of treatment. An initial cohort of 36 patients will be enrolled in a 10-week pilot phase. Accrual will be temporarily suspended while data from the pilot phase is assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria

Concurrent Medication:

Allowed:

• Chemoprophylaxis for Pneumocystis carinii pneumonia, candidiasis, Mycobacterium tuberculosis, and herpes as prescribed by the investigator.

• Recombinant erythropoietin and G-CSF if clinically indicated.

Patients must have:

• Documented HIV infection.

• CD4 count 300 - 500 cells/mm3.

• Prior AZT therapy for at least 3 months but less than 12 months prior to study entry.

• No past or current AIDS-defining opportunistic infection.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Kaposi's sarcoma requiring systemic therapy.

• Active malignancy other than basal cell carcinoma or in situ cervical carcinoma.

Concurrent Medication:

Excluded:

• Antiretroviral therapy other than AZT.

• Immunosuppressive drugs.

• Investigational HIV drugs/therapies other than study drug.

• Interferon.

• Steroids.

• Hematopoietins.

• Cytotoxic chemotherapy including Adriamycin, bleomycin, and vincristine.

Concurrent Treatment:

Excluded:

• Radiation therapy.

Patients with the following prior condition are excluded:

History of treatment-limiting intolerance to 500-600 mg AZT daily as manifested by the same recurrent grade 3 toxicity or any prior grade 4 toxicity.

Prior Medication:

Excluded:

• Prior antiretroviral therapy other than AZT.

Required:

• AZT for at least 3 months but no more than 12 months prior to study entry.

Study Design

Endpoint Classification: Pharmacokinetics Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Cysteamine

• Zidovudine

Locations

Country	Name	City	State
United States	Independent Research Nurses Inc	Cranston	Rhode Island
United States	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas
United States	Tulane Univ Med School	New Orleans	Louisiana
United States	SUNY / Health Sciences Ctr at Stony Brook	Stony Brook	New York
United States	Infectious Disease Research Institute Inc	Tampa	Florida
United States	Bowman Gray School of Medicine / North Carolina Baptist Hosp	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Mylan Laboratories

Country where clinical trial is conducted

United States,